Skip to main content
Clinical Trials/NCT04681404
NCT04681404
Recruiting
Not Applicable

Assessment of Balance, Function and Quality of Life in Patients Before and After Knee Replacement

Johannes Kepler University of Linz1 site in 1 country150 target enrollmentJanuary 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postural Balance
Sponsor
Johannes Kepler University of Linz
Enrollment
150
Locations
1
Primary Endpoint
Center of pressure track (COPT)
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Evaluation of patients before and after knee arthroplasty regarding balance, function and quality of life. Comparison of total and unicompartmental knee arthroplasty. Comparison of the primary outcome parameter and selected secondary outcome parameters to healthy controls.

Registry
clinicaltrials.gov
Start Date
January 11, 2021
End Date
December 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Johannes Kepler University of Linz
Responsible Party
Principal Investigator
Principal Investigator

Christian Mittermaier

Christian Mittermaier, MD

Johannes Kepler University of Linz

Eligibility Criteria

Inclusion Criteria

  • Primary gonarthrosis
  • planned TKA or UKA
  • adequate cognitive and lingual competence
  • informed consent

Exclusion Criteria

  • TKA or UKA revision
  • Surgery after trauma
  • Rheumatic disease
  • Neurologic disease
  • previous arthroplasty of the lower extremity (\<9 months)
  • cardiovascular disease
  • restricted weight bearing of the lower extremity after surgery

Outcomes

Primary Outcomes

Center of pressure track (COPT)

Time Frame: 1 year after surgery

Posturographic Parameter

Secondary Outcomes

  • Oxford Knee Score(Before surgery; 1 year after surgery)
  • Frequency of Sway(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • WOMAC Score(Before surgery; 1 year after surgery, higher score means better outcome)
  • Functional reach test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Timed up and go - test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Forgotten Joint Score(Before surgery; 1 year after surgery)
  • Knee Injury and Osteoarthritis Outcome Score(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • EQ-5D - Score(Before surgery; 1 year after surgery)
  • 10 m Walking test(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Knee Society Score(Before surgery; 1 year after surgery)
  • The University of California at Los Angeles Activity Score(Before surgery; 1 year after surgery)
  • Area of Sway(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Harmony Index(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Stability energy(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Movement control(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Feedback (visual, somatosensoric, vestibular)(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Weight Distribution Index(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)
  • Fulfillment of Tests(Before surgery; day 3-7 after surgery; 3 months and 1 year after surgery)

Study Sites (1)

Loading locations...

Similar Trials